Selan Antifungal by Trividia Manufacturing Solutions, Inc SELAN ANTIFUNGAL cream

Selan Antifungal by

Drug Labeling and Warnings

Selan Antifungal by is a Otc medication manufactured, distributed, or labeled by Trividia Manufacturing Solutions, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Miconazole nitrate 2%

Purpose

Antifungal

Uses

 - Cures most jock itch (tinea cruris), ringworm (tinea corporis), athlete's foot (tinea pedis) and superficial yeast infections

 - Relieves itching, cracking, burning, redness, irritation and discomfort associated with these conditions

Warnings

For external use only

DO NOT USE

Do not use on children under 2 years old unless directed by a doctor

WHEN USING

When using this product avoid contact with the eyes

STOP USE

Stop use and ask a doctor if irritation occurs or if there is no improvement

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

 - Clean affected area and dry thoroughly

 - Apply a thin layer over the affected area twice daily (morning and night) for 2 weeks (jock itch) or 4 weeks (athlete's foot & ringworm)

 - Supervise children in the use of this product

For athlete's foot  *pay special attention to the space between the toes  *wear well fitting, ventilated shoes  *change shoes and socks at least once daily

If condition persists longer, or if irritiation occurs, consult a doctor. This product is not effective on the scalp or nails.

Other information

store at room temperature

Inactive ingredients:

Dimethicone, emulsifying wax, fragrance, germaben II, lanolin, propylene glycol, water, zinc oxide

Image of 4oz tube

INGREDIENTS AND APPEARANCE

SELAN ANTIFUNGAL 
selan antifungal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0159-2500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
LANOLIN (UNII: 7EV65EAW6H)
DIMETHICONE 1000 (UNII: MCU2324216)
ZINC OXIDE (UNII: SOI2LOH54Z)
POLAWAX POLYSORBATE (UNII: Q504PL8E0V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0159-2500-04	117 g in 1 TUBE; Type 0: Not a Combination Product	11/05/2003

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	11/05/2003

Labeler - Trividia Manufacturing Solutions, Inc (018927392)

Establishment
Name	Address	ID/FEI	Business Operations
Trividia Manufacturing Solutions, Inc		018927392	manufacture(0159-2500) , label(0159-2500) , pack(0159-2500)